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Comparison of nanOss Cervical IBF System to C-Plus PEEK IBF Device With Autograft

NCT02586116 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2020-07-27

No results posted yet for this study

Summary

This is a post-market, prospective, randomized clinical investigation to evaluate the performance of the nanOss Cervical Interbody Fusion (IBF) device with nanOss Bioactive Bone Void Filler for the treatment of cervical disc disease. A secondary objective is to compare the performance of the nanOss Cervical IBF Device and nanOss Bioactive Bone Void Filler with the performance of the C-Plus PEEK IBF Device with autograft. This study will enroll 40 patients at one (1) site. After subjects have signed an informed consent, they will be randomly assigned to either the nanOss Cervical IBF device arm or the C-Plus PEEK IBF Device. Patients will complete the preoperative visit and examinations. Patients will be evaluated at discharge, six (6) weeks, three (3) months, six (6) months, and twelve (12) months. Patients will be evaluated at twenty-four (24) months post-operatively if they have not demonstrated fusion at the 12 month time point.

Conditions

  • Intervertebral Disc Degeneration

Interventions

DEVICE

nanOss

nanOss Cervical Interbody Fusion Device with nanOss BA bone void filler.

DEVICE

C-Plus

C-Plus PEEK IBF Device with autograft

Sponsors & Collaborators

  • RTI Surgical

    lead INDUSTRY

Principal Investigators

  • Dieter Peuskens, MD · Ziekenhuis Oost-Limburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2019-03-31
Completion
2019-03-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02586116 on ClinicalTrials.gov